FDA accepts UroGen’s UGN-103 bladder-cancer application for review
The FDA accepted UroGen Pharma’s NDA for UGN-103, an investigational treatment for adults with recurrent low-grade intermediate-risk non-muscle-invasive bladder cancer. The agency set June 14, 2027, as the PDUFA target action date. The application is supported by the Phase 3 UTOPIA study, in which 77.8% of patients achieved a complete response at three months, and UroGen’s U.S. patent protection for the product is expected to continue through July 2044.
Why it matters
FDA acceptance moves UGN-103 into formal regulatory review but does not represent an approval. UroGen will receive the agency’s decision by the stated target date unless the review timetable changes.
Key facts
- 1The FDA accepted UroGen’s NDA for UGN-103 and assigned June 14, 2027, as its PDUFA target action date. investing.com
- 2The Phase 3 UTOPIA study enrolled 99 patients and recorded a 77.8% complete-response rate at the three-month assessment. investing.com
- 3UroGen expects its U.S. patents covering the product’s technology and formulation to provide coverage through July 2044. investing.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.